Publicaciones científicas
Pomalidomide plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma and moderate renal impairment: a pooled analysis of three clinical trials.
Siegel DS (1), Weisel KC (2), Dimopoulos MA (3), Baz R (4), Richardson P (5), Delforge M (6), Song KW (7), San Miguel JF (8), Moreau P (9), Goldschmidt H (10), Cavo M (11), Jagannath S (12), Yu X (13), Hong K (13), Sternas L (13), Zaki M (13), Palumbo A (14).
RESUMEN
Renal impairment (RI) is a major comorbidity in patients with multiple myeloma (MM). Here we present the pooled safety and efficacy analysis of three clinical trials (MM-002, MM-003, and MM-010) of pomalidomide + low-dose dexamethasone (POM + LoDEX) in patients with moderate RI (creatinine clearance [CrCl] ≥ 30 to <60 mL/min) and without RI (≥ 60 mL/min).
Trial protocols were approved by the institutional review board of each site involved. Patients with RI were older than patients without RI, although other baseline characteristics were similar. The dosing and safety profile of POM + LoDEX was similar across RI subgroups.
Median overall response rate, progression-free survival, time to progression, and duration of response were not significantly different between RI subgroups. However, patients with vs. without RI had significantly shorter median overall survival (10.5 vs. 14.0 months, respectively; p = .004). This analysis demonstrates that POM + LoDEX is a safe and effective treatment for patients with moderate RI.
CITA DEL ARTÍCULO Leuk Lymphoma. 2016 Dec;57(12):2833-2838.
doi: 10.1080/10428194.2016.1177181. Epub 2016 Jun 7.